NCT03414515CompletedNot Applicable
Endovascular Treatment of Peripheral Artery Disease.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duomed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Binary restenosis
Study Overview
Brief Summary
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must sign the informed consent form prior to the index-procedure.
- •Patient is older than 18 years.
- •Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
- •Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
- •Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
- •Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).
Exclusion Criteria
- •Patients with Rutherford 0 and
- •Patient is pregnant.
- •Patients with estimated Glomerular filtration rate (eGFR) < 30 mL/min/1.73m
- •Patient has an acute thrombus or aneurysm in the target arteries.
- •Patient has a life expectancy of <12 months.
- •Patient has a target lesion that cannot be crossed with a guidewire.
- •Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
- •Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
- •Contraindication for anti-thrombotic therapy (coagulopathy, ...).
- •Patient has a known intolerance to anti-thrombotic medication or contrast agents.
Outcomes
Primary Outcomes
Binary restenosis
Time Frame: at 12 months follow-up
Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)
Secondary Outcomes
- Device-related complications(up to 12 months follow-up)
- Secondary sustained clinical improvement(at 12 months follow-up)
- Mortality(up to 12 months follow-up)
- Immediate procedural outcome(during index-procedure)
- Clinical outcome(at 12 months follow-up)
- Target lesion revascularization (TLR)(up to 12 months follow-up)
- Primary sustained clinical improvement(at 12 months follow-up)
- Amputation(up to 12 months follow-up)
Investigators
Study Sites (1)
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